The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
NCT ID: NCT02646267
Last Updated: 2016-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
210 participants
INTERVENTIONAL
2016-03-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard intensity warfarin group
standard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0)
standard intensity warfarin
target international normalised ratio(INR) was 2.1-3.0
low intensity warfarin group
low intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2)
low intensity warfarin
target international normalised ratio(INR) was 1.7-2.2
dabigatran etexilate group
110mg dabigatran etexilate was administrated twice a day
dabigatran etexilate
110mg, twice a day, oral
Interventions
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standard intensity warfarin
target international normalised ratio(INR) was 2.1-3.0
low intensity warfarin
target international normalised ratio(INR) was 1.7-2.2
dabigatran etexilate
110mg, twice a day, oral
Eligibility Criteria
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Inclusion Criteria
2. Echocardiography confirmed a non-valvular heart disease
3. Age≥60 years
Exclusion Criteria
2. CHA2DS2-VASc\<2
3. Life expectancy of less than 1 year
4. Rheumatic heart disease or dilated cardiomyopathy
5. History of artificial valve replacement surgery
6. Infectious endocarditis
7. Stroke or transient ischemic attack(TIA) within the last 6 months
8. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
9. Previous intolerance/allergy to warfarin or dabigatran etexilate
10. Blood pressure greater than 180/110 mmHg
11. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
12. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
13. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
60 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Wu Jun, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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References
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Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.
Other Identifiers
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SEL102
Identifier Type: -
Identifier Source: org_study_id
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